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Adverse events (including serious adverse events (SAEs), serious suspected adverse reactions and suspected unexpected serious adverse events) will be summarised by treatment group and the relationship between events and study treatment or underlying RA will be assessed.
Safety and toxicity: Safety analyses will summarise the adverse events (including serious adverse events (SAEs), serious suspected adverse reactions and suspected unexpected serious adverse events), laboratory changes and treatment-related mortality rates.
suspected unexpected serious adverse reactions.
No suspected unexpected serious adverse reactions (SUSARs) were recorded.
No suspected, unexpected, serious adverse reactions (SUSARS) were reported during the trial.
No suspected unexpected serious adverse events occurred during the reporting period of the study.
Any suspected unexpected serious adverse reaction (SUSAR) will be reported to the Spanish Agency (AEMPS).
One suspected unexpected serious adverse reaction (a ruptured abdominal aortic aneurysm) was reported during the trial.
No suspected unexpected serious adverse reactions were observed in any of the subjects.
One suspected unexpected serious adverse reaction (SUSAR) occurred within 1 year.
No severe adverse events or suspected unexpected serious adverse reactions occurred during this study.
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